Know Cancer

or
forgot password

Yoga and Brain Cancer: A Feasibility Study


N/A
18 Years
N/A
Not Enrolling
Both
Adult Anaplastic Astrocytoma, Adult Anaplastic Ependymoma, Adult Anaplastic Meningioma, Adult Anaplastic Oligodendroglioma, Adult Brain Stem Glioma, Adult Choroid Plexus Tumor, Adult Diffuse Astrocytoma, Adult Ependymoblastoma, Adult Ependymoma, Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Adult Grade II Meningioma, Adult Medulloblastoma, Adult Meningeal Hemangiopericytoma, Adult Mixed Glioma, Adult Oligodendroglioma, Adult Papillary Meningioma, Adult Pineal Gland Astrocytoma, Adult Pineoblastoma, Adult Pineocytoma, Adult Supratentorial Primitive Neuroectodermal Tumor (PNET), Recurrent Adult Brain Tumor

Thank you

Trial Information

Yoga and Brain Cancer: A Feasibility Study


PRIMARY OBJECTIVES:

I. To estimate the participation rate, accrual, adherence, and retention to a yoga trial in
patients with malignant brain tumors.

SECONDARY OBJECTIVES:

I. To obtain estimates of the variability of self-reported fatigue, distress (i.e.,
depression, anxiety), sleep disturbance, cognitive function, and health-related quality of
life from baseline to the end of the intervention at 6 (post-onsite intervention) and 12
weeks (post-full intervention).

II. To obtain preliminary estimates of the efficacy of a yoga intervention in patients with
malignant brain tumors on the outcomes of fatigue, distress, and cognitive function.

III. To standardize the cancer-specific yoga protocol for use with brain tumor patients.

OUTLINE:

Patients participate in yoga classes comprising postures, deep relaxation, breathing
practices, and meditation twice weekly for 75 minutes during weeks 1-6. Patients then
practice yoga at home twice weekly for 45 minutes during weeks 7-12.

After completion of study treatment, patients are followed up periodically for 4-5 months.


Inclusion Criteria:



Signed protocol specific informed consent Are diagnosed with a Malignant Brain Tumor
(Grades II-IV) Able to start the on-site yoga intervention within 1 week of first
radiation treatment Are physically able to attend the intervention classes (Eastern
Cooperative Oncology Group [ECOG] performance status rating 0-2) Able to understand
written and spoken English Have no medical contraindications reported by the attending
physician

Exclusion Criteria:

Have practiced yoga on a regular basis (at least once a week) within the past 4 weeks to
recruit participants who are not already regularly practicing yoga; given that the
benefits of yoga are likely more immediate than long-term, however, we will enroll
participants who have previously had a yoga practice

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Estimate the participation rate, accrual, adherence, and retention to a yoga trial in patients with malignant brain tumors

Outcome Description:

Track barriers to recruitment. Participation rate calculated as proportion of eligible patients who agree to participate. Study retention estimated as proportion of participating patients who complete questionnaires at Week 6. Further retention data obtained by tracking # of dropouts, when dropout occurs, & reasons for dropout. Intervention adherence estimated as mean % of yoga classes attended. Summary statistics for patient characteristics, participation rates, adherence & retention. 95% confidence intervals calculated for each feasibility measure.

Outcome Time Frame:

Up to 12 weeks

Safety Issue:

No

Principal Investigator

Suzanne Danhauer

Investigator Role:

Principal Investigator

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CCCWFU 98410

NCT ID:

NCT01234805

Start Date:

December 2010

Completion Date:

Related Keywords:

  • Adult Anaplastic Astrocytoma
  • Adult Anaplastic Ependymoma
  • Adult Anaplastic Meningioma
  • Adult Anaplastic Oligodendroglioma
  • Adult Brain Stem Glioma
  • Adult Choroid Plexus Tumor
  • Adult Diffuse Astrocytoma
  • Adult Ependymoblastoma
  • Adult Ependymoma
  • Adult Giant Cell Glioblastoma
  • Adult Glioblastoma
  • Adult Gliosarcoma
  • Adult Grade II Meningioma
  • Adult Medulloblastoma
  • Adult Meningeal Hemangiopericytoma
  • Adult Mixed Glioma
  • Adult Oligodendroglioma
  • Adult Papillary Meningioma
  • Adult Pineal Gland Astrocytoma
  • Adult Pineoblastoma
  • Adult Pineocytoma
  • Adult Supratentorial Primitive Neuroectodermal Tumor (PNET)
  • Recurrent Adult Brain Tumor
  • Astrocytoma
  • Brain Neoplasms
  • Ependymoma
  • Glioblastoma
  • Glioma
  • Hemangiopericytoma
  • Medulloblastoma
  • Meningioma
  • Oligodendroglioma
  • Pinealoma
  • Choroid Plexus Neoplasms
  • Neuroectodermal Tumors
  • Neuroectodermal Tumors, Primitive
  • Gliosarcoma

Name

Location
Comprehensive Cancer Center of Wake Forest University Winston-Salem, North Carolina  27157-1082